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Simvastatin for the prevention of exacerbations in moderate-to-severe COPD.

Abstract

BACKGROUND

Retrospective studies have shown that statins decrease the rate and severity of exacerbations, the rate of hospitalization, and mortality in chronic obstructive pulmonary disease (COPD). We prospectively studied the efficacy of simvastatin in preventing exacerbations in a large, multicenter, randomized trial.

METHODS

We designed the Prospective Randomized Placebo-Controlled Trial of Simvastatin in the Prevention of COPD Exacerbations (STATCOPE) as a randomized, controlled trial of simvastatin (at a daily dose of 40 mg) versus placebo, with annual exacerbation rates as the primary outcome. Patients were eligible if they were 40 to 80 years of age, had COPD (defined by a forced expiratory volume in 1 second [FEV1] of less than 80% and a ratio of FEV1 to forced vital capacity of less than 70%), and had a smoking history of 10 or more pack-years, were receiving supplemental oxygen or treatment with glucocorticoids or antibiotic agents, or had had an emergency department visit or hospitalization for COPD within the past year. Patients with diabetes or cardiovascular disease and those who were taking statins or who required statins on the basis of Adult Treatment Panel III criteria were excluded. Participants were treated from 12 to 36 months at 45 centers.

RESULTS

A total of 885 participants with COPD were enrolled for approximately 641 days; 44% of the patients were women. The patients had a mean (±SD) age of 62.2±8.4 years, an FEV1 that was 41.6±17.7% of the predicted value, and a smoking history of 50.6±27.4 pack-years. At the time of study closeout, the low-density lipoprotein cholesterol levels were lower in the simvastatin-treated patients than in those who received placebo. The mean number of exacerbations per person-year was similar in the simvastatin and placebo groups: 1.36±1.61 exacerbations and 1.39±1.73 exacerbations, respectively (P=0.54). The median number of days to the first exacerbation was also similar: 223 days (95% confidence interval [CI], 195 to 275) and 231 days (95% CI, 193 to 303), respectively (P=0.34). The number of nonfatal serious adverse events per person-year was similar, as well: 0.63 events with simvastatin and 0.62 events with placebo. There were 30 deaths in the placebo group and 28 in the simvastatin group (P=0.89).

CONCLUSIONS

Simvastatin at a daily dose of 40 mg did not affect exacerbation rates or the time to a first exacerbation in patients with COPD who were at high risk for exacerbations. (Funded by the National Heart, Lung, and Blood Institute and the Canadian Institutes of Health Research; STATCOPE ClinicalTrials.gov number, NCT01061671.).

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    Source

    The New England journal of medicine 370:23 2014 Jun 05 pg 2201-10

    MeSH

    Adult
    Aged
    Female
    Forced Expiratory Volume
    Humans
    Hydroxymethylglutaryl-CoA Reductase Inhibitors
    Lipids
    Male
    Middle Aged
    Prospective Studies
    Pulmonary Disease, Chronic Obstructive
    Quality of Life
    Severity of Illness Index
    Simvastatin
    Treatment Failure
    Vital Capacity

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    24836125

    Citation

    Criner, Gerard J., et al. "Simvastatin for the Prevention of Exacerbations in Moderate-to-severe COPD." The New England Journal of Medicine, vol. 370, no. 23, 2014, pp. 2201-10.
    Criner GJ, Connett JE, Aaron SD, et al. Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. N Engl J Med. 2014;370(23):2201-10.
    Criner, G. J., Connett, J. E., Aaron, S. D., Albert, R. K., Bailey, W. C., Casaburi, R., ... Lazarus, S. C. (2014). Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. The New England Journal of Medicine, 370(23), pp. 2201-10. doi:10.1056/NEJMoa1403086.
    Criner GJ, et al. Simvastatin for the Prevention of Exacerbations in Moderate-to-severe COPD. N Engl J Med. 2014 Jun 5;370(23):2201-10. PubMed PMID: 24836125.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. AU - Criner,Gerard J, AU - Connett,John E, AU - Aaron,Shawn D, AU - Albert,Richard K, AU - Bailey,William C, AU - Casaburi,Richard, AU - Cooper,J Allen D,Jr AU - Curtis,Jeffrey L, AU - Dransfield,Mark T, AU - Han,MeiLan K, AU - Make,Barry, AU - Marchetti,Nathaniel, AU - Martinez,Fernando J, AU - Niewoehner,Dennis E, AU - Scanlon,Paul D, AU - Sciurba,Frank C, AU - Scharf,Steven M, AU - Sin,Don D, AU - Voelker,Helen, AU - Washko,George R, AU - Woodruff,Prescott G, AU - Lazarus,Stephen C, AU - ,, AU - ,, Y1 - 2014/05/18/ PY - 2014/5/20/entrez PY - 2014/5/20/pubmed PY - 2014/6/11/medline SP - 2201 EP - 10 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 370 IS - 23 N2 - BACKGROUND: Retrospective studies have shown that statins decrease the rate and severity of exacerbations, the rate of hospitalization, and mortality in chronic obstructive pulmonary disease (COPD). We prospectively studied the efficacy of simvastatin in preventing exacerbations in a large, multicenter, randomized trial. METHODS: We designed the Prospective Randomized Placebo-Controlled Trial of Simvastatin in the Prevention of COPD Exacerbations (STATCOPE) as a randomized, controlled trial of simvastatin (at a daily dose of 40 mg) versus placebo, with annual exacerbation rates as the primary outcome. Patients were eligible if they were 40 to 80 years of age, had COPD (defined by a forced expiratory volume in 1 second [FEV1] of less than 80% and a ratio of FEV1 to forced vital capacity of less than 70%), and had a smoking history of 10 or more pack-years, were receiving supplemental oxygen or treatment with glucocorticoids or antibiotic agents, or had had an emergency department visit or hospitalization for COPD within the past year. Patients with diabetes or cardiovascular disease and those who were taking statins or who required statins on the basis of Adult Treatment Panel III criteria were excluded. Participants were treated from 12 to 36 months at 45 centers. RESULTS: A total of 885 participants with COPD were enrolled for approximately 641 days; 44% of the patients were women. The patients had a mean (±SD) age of 62.2±8.4 years, an FEV1 that was 41.6±17.7% of the predicted value, and a smoking history of 50.6±27.4 pack-years. At the time of study closeout, the low-density lipoprotein cholesterol levels were lower in the simvastatin-treated patients than in those who received placebo. The mean number of exacerbations per person-year was similar in the simvastatin and placebo groups: 1.36±1.61 exacerbations and 1.39±1.73 exacerbations, respectively (P=0.54). The median number of days to the first exacerbation was also similar: 223 days (95% confidence interval [CI], 195 to 275) and 231 days (95% CI, 193 to 303), respectively (P=0.34). The number of nonfatal serious adverse events per person-year was similar, as well: 0.63 events with simvastatin and 0.62 events with placebo. There were 30 deaths in the placebo group and 28 in the simvastatin group (P=0.89). CONCLUSIONS: Simvastatin at a daily dose of 40 mg did not affect exacerbation rates or the time to a first exacerbation in patients with COPD who were at high risk for exacerbations. (Funded by the National Heart, Lung, and Blood Institute and the Canadian Institutes of Health Research; STATCOPE ClinicalTrials.gov number, NCT01061671.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/24836125/Simvastatin_for_the_prevention_of_exacerbations_in_moderate_to_severe_COPD_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa1403086?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=www.ncbi.nlm.nih.gov DB - PRIME DP - Unbound Medicine ER -